The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Urine Benzodiazepines (benz) Screen Flex Reagent Cartridge, Catalog No. Df 92a.
| Device ID | K000458 |
| 510k Number | K000458 |
| Device Name: | URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Contact | Judy Mcinnis-berger |
| Correspondent | Judy Mcinnis-berger DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005879 | K000458 | 000 |